The Recall Desk
ModerateFDA (Devices)·Z-2514-2025·Announced 2025-09-10

Dental Implant Titanium Base Recalled for Manufacturing Misalignment

Preat Corp is recalling NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base units due to a manufacturing defect causing 180-degree misalignment. The error prevents dental crowns from fitting properly onto the abutment, resulting in restoration delays.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations, injuries, or deaths. The manufacturing defect impairs device functionality through orientation error, causing restoration delays, but does not represent a direct safety hazard or risk of injury.

Plain-English summary

Preat Corp is recalling NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base components due to a manufacturing defect. The engaging titanium base was positioned 180 degrees around the post from where it should be located in relation to the connection geometry, placing the flat surface on the wrong side of the post.

As a result of this misalignment, dental crowns will not fit onto the abutment in the correct orientation. This causes restoration delays and prevents proper installation of the dental restoration. The defect affects 11 units with Lot 277097 (UDI-DI: 00842092169599) that were distributed nationwide in New York, Florida, Pennsylvania, California, and Ohio.

Patients who received treatment at affected facilities should contact their dental provider if they have concerns about their implant restoration. Healthcare providers should refer to the FDA recall notice for additional information and handling instructions.

The recalled product

Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Manufacturer
Preat Corp
Category
Medical Device — Dental implant component
Hazard
  • manufacturing-defect
  • misalignment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00842092169599. Lot: 277097

Distribution

Distributed nationwide across the United States.

Related recalls

Same category